FDA.reportPublic FDA data

MAUDE MDR 4755195

MDR report key
4755195
Report number
4755195
Event key
0
Event type
3
Date of event
2015-05-05
Date received
2015-05-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CHILDREN'S MEDICAL VENTURESSOOTHIE NEWBORN PACIFIERPHILIPS CHILDREN'S MEDICAL VENTURESLQX*96004-N* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-05-060

Event Narratives#

D

Patient 1

CONCERN FOR POTENTIAL HARM TO INFANT WHEN MEMBRANE ON PACIFIER COMES OUT (SMALL HOLE LOCATED IN MIDDLE OF PACIFIER DISLODGES). POTENTIAL FOR ASPIRATION.======================MANUFACTURER RESPONSE FOR SOOTHIE NEWBORN PACIFIER, CHILDREN'S MEDICAL VENTURES (PER SITE REPORTER).======================CONTACTED REP AND ORDER NUMBER WAS GIVEN.